Fahrleitner-Pammer A, Papaioannou N, Gielen E, Feudjo Tepie M, Toffis C, Frieling I, Geusens P, Makras P, Boschitsch E, Callens J, Anastasilakis A D, Niedhart C, Resch H, Kalouche-Khalil L, Hadji P
Department of Endocrinology and Metabolism, Medical University Graz, Graz, Austria.
Medical School, Laboratory for the Research of Musculoskeletal System, KAT Hospital, University of Athens, Athens, Greece.
Arch Osteoporos. 2017 Dec;12(1):58. doi: 10.1007/s11657-017-0351-2. Epub 2017 Jun 22.
Persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium found that persistence with denosumab remains consistently high after 24 months in patients at high risk of fracture.
Continued persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of clinical practice evaluated medication-taking behavior of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium and factors influencing persistence.
Subcutaneous denosumab (60 mg every 6 months) was assigned according to prescribing information and local guidelines before and independently of enrollment; outcomes were recorded during routine practice for up to 24 months. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection and adherence as administration of subsequent injections within 6 months ± 4 weeks of the previous injection. Medication coverage ratio (MCR) was calculated as the proportion of time a patient was covered by denosumab. Associations between pre-specified baseline covariates and 24-month persistence were assessed using multivariable logistic regression.
The 24-month analyses included 1479 women (mean age 66.3-72.5 years) from 140 sites; persistence with denosumab was 75.1-86.0%, adherence 62.9-70.1%, and mean MCR 87.4-92.4%. No covariate had a significant effect on persistence across all four countries. For three countries, a recent fall decreased persistence; patients were generally older with chronic medical conditions. In some countries, other covariates (e.g., older age, comorbidity, immobility, and prescribing reasons) decreased persistence. Adverse drug reactions were reported in 2.3-6.9% patients.
Twenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics. Further studies are needed to identify determinants of low persistence.
坚持骨质疏松症治疗对于预防骨折至关重要。这项针对德国、奥地利、希腊和比利时接受地诺单抗治疗的绝经后女性的非干预性研究发现，骨折高危患者使用地诺单抗24个月后的持续使用率一直很高。
持续坚持骨质疏松症治疗对于预防骨折至关重要。这项临床实践的非干预性研究评估了德国、奥地利、希腊和比利时接受地诺单抗治疗的绝经后女性的用药行为及影响持续用药的因素。
皮下注射地诺单抗（每6个月60毫克），给药依据处方信息和当地指南，在入组前且独立于入组情况进行；在常规诊疗过程中记录长达24个月的结果。持续用药定义为在上次注射后6个月加8周内接受后续注射，依从性定义为在上次注射后6个月±4周内进行后续注射。用药覆盖率（MCR）计算为患者接受地诺单抗覆盖的时间比例。使用多变量逻辑回归评估预先指定的基线协变量与24个月持续用药之间的关联。
24个月的分析纳入了来自140个地点的1479名女性（平均年龄66.3 - 72.5岁）；地诺单抗的持续使用率为75.1 - 86.0%，依从率为62.9 - 70.1%，平均MCR为87.4 - 92.4%。在所有四个国家中，没有协变量对持续用药有显著影响。在三个国家，近期跌倒会降低持续使用率；患者通常年龄较大且患有慢性疾病。在一些国家，其他协变量（如年龄较大、合并症、行动不便和处方原因）会降低持续使用率。2.3 - 6.9%的患者报告了药物不良反应。
在欧洲绝经后女性中，地诺单抗24个月的持续使用率一直很高，且可能受患者特征影响。需要进一步研究以确定低持续使用率的决定因素。
